Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc.
NEWMAN, O’MALLEY, TARANTO
December 17, 2020
Brief Summary: DC decision affirmed based on claim construction and Maia’s stipulation to infringement (e.g., technical construction errors “harmless”). Summary: Maia appealed DC finding that its sincalide product (ANDA of Kinevac®) infringed Bracco’s US 6,803,046 based on the claim construction of the terms buffer, surfactant/solublizer, and surfactant. The FC panel opinion explains that while “sincalide was originally introduced in 1976, the ‘046 patent purports to teach sincalide formulations that are ‘purer than prior art formulations, and have fewer degradants and more consistent potency’ in part through addition of excipients such as buffers, surfactants/solublizers, and surfactants”, which are required by the claims. Regarding the claim term “buffer”, the DC “imported into its definition the list of exemplary buffering agents from the specification” including amino acids and “rejected Maia’s proposal to construe the term buffer to mean ‘[a] compound that stabilizes the pH of a sincalide formulation’”. The DC also “imported a list of preferred surfactants/solubilizers from the specification into its definition of the term” and “rejected Maia’s proposal to construe” it “to mean ‘[a] surfactant is also a solubilizer’…that aids in solubilization” of sincalide. And the DC construed the claim term “surfactant” as “[a]n excipient that may reduce the interfacial tension”, rejecting “Maia’s proposal to construe” it “to mean ‘[a] compound that reduces the tension of the air/liquid or liquid/solid interface’” and “Bracco’s proposal to import a list of exemplary surfactants/solubilizers from the specification into its definition.” In view of these constructions, Maia stipulated to infringement. In this appeal, Maia argued that the DC “erroneously included amino acids in its definitions of buffer and surfactant/solubilizer, erroneously constructed the backslash between surfactant/solubilizer to mean ‘and’ or ‘or,’ and erroneously included ‘may’ in its definition of surfactant.” Maia argued that the amino acids in its product do not “have buffering effects” and its stipulation “is only an admission that” it “has amino acids”. The FC panel agreed the DC “technically erred in importing” the specification’s list of buffers but that dependent “claim 3…recites…one or more amino acids” rendering that error “harmless.” Maia also “argued that the claims are invalid as inoperable, because…amino acids are not buffers” but the FC panel found it “relinquished those arguments when it stipulated to infringement and dismissal of its counterclaims of invalidity” (Inventio, FC 2012). The FC panel similarly found that the DC “technically erred in importing a list of excipients into its definition of surfactant/solubilizer” but was “harmless” because it was “essentially correct in its functional definition” and Maia is bound by its stipulation that it infringed “every limitation of the claims, not just to having amino acids”. The FC panel also rejected Maia’s argument that the slash between the terms “describe[s] one excipient that has multiple functions”, finding the DC correctly construed it “to mean ‘and’ or ‘or’” based on the plain language of the claims (e.g., dependent claims) and the specification (Hill-Rom, FC 2014 (no “clear intention to limit the claim scope”)). The FC panel also concluded the DC correctly construed surfactant and that its “use of the word ‘may’ in its construction does not render surfactant meaningless” (“standing alone, [it] presents some ambiguity”) and “the specification’s disclosure that one type of surfactant ‘may reduce the interfacial tension,’ supports the [DC’s] construction that surfactants need not necessarily reduce interfacial tension” (Imaginal Sys., FC 2015 (“cautioned against limiting the claimed invention to preferred embodiments or specific examples in the specification”); “supported by the extrinsic evidence”). Thus, the DC decision was affirmed.